Surgical system with clips for identifying the orientation of a tissue sample

ABSTRACT

A tissue marking system for use in marking a tissue sample comprises an ink-based applicator device and at least one tissue marking clip. The ink-based applicator device includes a container, a first number of ink reservoirs at least partially defined by the container, wherein each reservoir contains ink of a different color, a second number of applicators, wherein each applicator is configured to absorb a quantity of ink for application to the tissue sample, and a cover coupled to and cooperating with the container to fully enclose each of the first number of ink reservoirs. The at least one tissue marking clip includes an actuator portion movable between an actuated position and a non-actuated position, and a jaw portion coupled to the actuator portion and movable between an open position and a closed position in response to movement of the actuator portion between the actuated and non-actuated positions.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation-in-part of U.S. application Ser. No.11/749,552, filed May 16, 2007, which claims the benefit of U.S.Provisional Ser. No. 60/800,714, filed May 16, 2006, the entireties ofwhich are hereby incorporated by reference. This application is also acontinuation-in-part of U.S. application Ser. No. 11/873,249, filed Oct.16, 2007, which is a continuation-in-part and claims the benefit of U.S.application Ser. No. 10/978,948, filed Nov. 1, 2004, the entireties ofwhich are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates to a tissue marking system. Moreparticularly, the present invention relates to a tissue marking systemthat identifies tissue orientation during both radiographic and visualexamination.

During surgery, it is often necessary to remove a sample of tissue andclosely examine that tissue sample (e.g., radiographic examination)while knowing its original orientation within the patient. For example,cancerous tumors are often removed from the patient and then examined toverify that a sufficient margin of tissue surrounding the tumor has beenremoved. To determine this, the tissue sample is examined and themargins on each surface are identified. If a margin is insufficient, itis important for the surgeon to know the orientation of the sample toallow for the removal of additional tissue in the proper area.

Presently, different color sutures, different length sutures, ordifferent quantities of sutures are inserted into the tissue sample toidentify the orientation of the tissue. However, this is time consumingand the sutures can be accidentally removed making identification of thetissue orientation difficult. Furthermore, sutures are not visible inradiographic (X-ray) images. As such, the tissue sample must be markedin a second way to provide for orientation in any X-ray images that maybe taken.

SUMMARY OF THE INVENTION

The present invention solves the foregoing problems by providing atissue marking system for use in marking a tissue sample that comprisesan ink-based applicator device and at least one tissue marking clip. Theink-based applicator device includes a container, a first number of inkreservoirs at least partially defined by the container, wherein eachreservoir contains ink of a different color, a second number ofapplicators, wherein each applicator is configured to absorb a quantityof ink for application to the tissue sample, and a cover coupled to andcooperating with the container to fully enclose each of the first numberof ink reservoirs. The at least one tissue marking clip includes anactuator portion movable between an actuated position and a non-actuatedposition, and a jaw portion coupled to the actuator portion and movablebetween an open position and a closed position in response to movementof the actuator portion between the actuated and non-actuated positions.The jaw portion includes a first tooth and a second tooth configured toengage the tissue sample when the jaw portion moves from the openposition to the closed position.

In another aspect of the invention, a tissue marking method for markinga tissue sample is provided that comprises the steps of providing acontainer including a first ink reservoir containing a first color ink,a second ink reservoir containing a second color ink, and a third inkreservoir containing a third color ink, applying the first color ink toa first surface of the tissue sample, applying the second color ink to asecond surface of the tissue sample, applying the third color ink to athird surface of the tissue sample, providing first, second, and thirdtissue marking clips, wherein each of the tissue marking clips includesan actuator portion movable between a non-actuated position and anactuated position and a jaw portion coupled to the actuator portion andmovable between an open position and a closed position in response tomovement of the actuator portion, clipping the first tissue marking clipon the first surface of the tissue sample, clipping the second tissuemarking clip on the second surface of the tissue sample, and clippingthe third tissue marking clip on the third surface of the tissue sample.

Other aspects of the invention will become apparent by consideration ofthe detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a patient including a tissue sample to beremoved from the patient;

FIG. 2 is an enlarged top view of a portion of the patient and tissuesample of FIG. 1;

FIG. 3 is a side view of the portion of the patient and tissue sample ofFIG. 1;

FIG. 4 is a perspective view of the tissue sample of FIG. 1 after beingremoved from the patient of FIG. 1;

FIG. 5 is a perspective view of a tissue marking system;

FIG. 6 is a top view of another tissue marking system;

FIG. 6 a is a sectional view of the tissue marking system of FIG. 6taken along line A-A of FIG. 6;

FIG. 7 is a sectional view of the tissue marking system of FIG. 6 takenalong line 7-7 of FIG. 6;

FIG. 8 is a perspective view of another construction of the tissuemarking system;

FIG. 9 is a perspective view of an applicator;

FIG. 10 is a perspective view of another construction of the tissuemarking system;

FIG. 11 is an enlarged perspective view of the tissue sample of FIG. 4;

FIG. 12 is a front perspective view of a clip that is attachable to thetissue sample of FIG. 11;

FIG. 13 is top perspective view of the clip of FIG. 12;

FIG. 14 is a front perspective view of the clip of FIG. 12 in anactuated position;

FIG. 15 is a front perspective view of another clip in a non-actuatedposition;

FIG. 16 is an exploded front view of a portion of the clip of FIG. 15;

FIG. 17 is a section view of a portion of the clip of FIG. 15 takenalong line 17-17 of FIG. 15; and

Before any embodiments of the invention are explained, it is to beunderstood that the invention is not limited in its application to thedetails of construction and the arrangements of components set forth inthe following description or illustrated in the following drawings. Theinvention is capable of other embodiments and of being practiced or ofbeing carried out in various ways. Also, it is to be understood that thephraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof is meantto encompass the items listed thereafter and equivalence thereof as wellas additional items. The terms “connected,” “coupled,” and “mounted” andvariations thereof are used broadly and encompass direct and indirectconnections, couplings, and mountings. In addition, the terms“connected” and “coupled” and variations thereof are not restricted tophysical or mechanical connections or couplings.

DETAILED DESCRIPTION OF THE INVENTION

With reference to FIGS. 1-3, a patient 10 and a tissue sample 15 areillustrated to show the tissue sample's orientation in the patient 10.Before proceeding, it should be noted that the present invention will bedescribed as it relates to a tissue sample 15 removed from a breast.However, one of ordinary skill in the art will realize that theinvention is applicable to many other tissue samples in whichorientation is important. For example, basal cell carcinoma alsorequires that a tissue sample be removed, and that its orientation beidentified to verify that sufficient margin has been removed. As such,the invention should not be limited only to the uses described herein asit is well suited for use with any tissue that required orientation forpathology and/or radiology. These tissues include but are not limited tosamples of breast, bone, thyroid, lymph nodes, brain, sarcomas, kidney,bowel, spleen, soft tissue masses, melanoma, squamous cell skin cancer,basal cell cancer, liver tumors, and the like.

FIG. 1 shows a view looking down on the patient 10. For purposes ofdescription, the direction 20 toward the patient's head will beidentified as superior, while the opposite direction 25 is inferior. Thedirection 30 toward the patient's midline is defined as medial, whilethe opposite direction 35 is defined as lateral. With reference to FIG.3, a side view of a portion of the patient is illustrated to furtherillustrate orientation. The direction 40 toward the patient's exterioris defined as superficial, while the opposite direction 45 is defined asdeep.

FIGS. 2 and 3 illustrate the tissue sample 15 within the patient 10prior to its removal, while FIG. 4 shows that same tissue sample 15after removal. With the sample 15 still in the patient 10, the threesurfaces 50, 55, 60 that will be marked can be seen. While any threeplanes or surfaces of the tissue sample 15 can be used to identify theorientation of the sample 15, it is preferred that at least threesubstantially orthogonal surfaces be identified, with some applicationsmarking six surfaces. In FIGS. 2 and 3, the lateral surface 50, inferiorsurface 55, and superficial surface 60 of the tissue sample 15 areshaded differently for illustrative purposes. In FIG. 4, the same threesurfaces 50, 55, 60 are shaded to indicate that they have been markedwith a different color.

Before proceeding, it should be noted that the term “ink” as used hereinis meant to encompass any coloring element that can be applied to atissue sample 15, with dye, paint, and stains being a few examples. Assuch, the invention should not be limited to ink alone.

To mark the surfaces 50, 55, 60, three different color inks areemployed. FIG. 5 illustrates a container 80 suited for use in markingthe tissue sample 15. The container 80 includes a housing 85 thatdefines three substantially separated compartments 90, 95, 100 and acover 105 pivotally attached to the housing 85. A perimeter 86 extendsaround the container 80 and encircles the three compartments 90, 95,100. Each of the three different color inks is disposed within one ofthe three compartments 90, 95, 100. The cover 105 is movable between acovering position where it covers the three compartments 90, 95, 100 andcooperates with the housing 85 to completely separate the compartments90, 95, 100, and an open position where the ink is accessible.

Each compartment 90, 95, 100 includes a bottom surface and a wall thatsurrounds the bottom surface. Opposite the bottom surface is an openingthat allows for access to the ink during use.

In some constructions, each of the inks is simply disposed within one ofthe compartments 90, 95, 100. Generally, the ink in the compartments isin liquid form. In other constructions, an ink absorbent material 110,such as foam or felt, is disposed within each compartment 90, 95, 100and is operable to absorb and hold the ink to inhibit spillage andmixing between the ink compartments 90, 95, 100.

Each quantity of ink is a different color than the remaining twoquantities of ink. Thus, the first quantity of ink may be yellow, thesecond quantity of ink may be red, and the third quantity of ink may beblack. Of course different colors (e.g., black, blue, green, red,yellow, orange, violet, and the like) could also be employed if desired.In addition, different colors may be employed depending on theparticular tissue sample 15 to be removed. For example, breast tissuemay be better examined if yellow, red, and blue inks are used, whilebasal cell samples may be better examined using red, blue, and blackink. Thus, the actual colors employed may be varied greatly.

Generally, the container 80 is a single use tool that is used during asingle surgical procedure or a series of surgical procedures performedduring the course of a single day. Thus, the container 80 and itscontents are sterilized. While many different sterilization proceduresare possible, it is believed that gamma ray sterilization is best suitedto the task of sterilizing the container 80 and its contents with othersterilization processes also being possible. The container is subjectedto a sufficient time and duration of gamma irradiation to render saidcontainer sufficiently sterile for introduction into a surgicaloperating room. In some constructions, a forceps 115 or tweezers isattached to the cover 105 and can be removed for use in grasping andmarking the tissue sample 15. Thus, the tissue sample 15 can be markedusing the enclosed forceps 115 and the forceps 115 and the container 80can be discarded after use.

While many different manufacturing processes are possible it ispreferred that the container 80, including the cover 105, be injectionmolded as a single component. In constructions that are molded as asingle component, a living hinge 118 would generally be employed betweenthe cover 105 and the housing 85. Of course, other manufacturing methodsand other connections between the cover 105 and housing 85 could beemployed if desired.

FIG. 6 illustrates another container 120 that supports three inkreservoirs 125, 126, 127 and is suited for use in marking the tissuesample 15. Like the container 80, the container 120 is a single use toolthat is used during a surgical procedure or a series of surgicalprocedures throughout a day. For example, one container could be openedduring a first surgical procedure and could be used throughout the dayfor a series of procedures before being discarded. In preferredconstructions, the container 120 and its contents are sterilized beforethey are opened. The container 120 includes a formed portion 130 thatdefines the three ink reservoirs 125, 126, 127. The reservoirs 125, 126,127 are slight depressions in the formed portion 130 that are sized tocontain a quantity of ink. A first isolation space 140 is formed betweenthe first reservoir 125 and the second reservoir 126 and a secondisolation space 145 is formed between the second reservoir 126 and thethird reservoir 127. The formed portion 130 also defines a perimeter 150that surrounds the three reservoirs 125, 126, 127. In mostconstructions, the perimeter 150, the first isolation space 140, and thesecond isolation space 145 are all substantially disposed within asingle plane and the reservoirs 125, 126, 127 extend below that plane.

In some constructions, a ridge 155 (shown in FIG. 6 a) is formed aroundthe perimeter 150 to increase the stiffness of the formed portion 130.The ridge 155 may have a semi-circular, square, triangular, polygonal,or any other suitable cross-section. Generally, the ridge 155 extendsdownward below the perimeter to provide the additional stiffness. Theridge 155 also reduces the likelihood of tearing a surgical glove byreducing the number of sharp edges. The increased stiffness that resultsfrom the ridge 155 allows the container 120 to be used without beingcompletely supported from beneath the reservoirs 125, 126, 127.

The ink, dye, or other marking substance is disposed within each of thereservoirs 125, 126, 127. As discussed with regard to FIG. 5, an inkabsorbing material 160 such as felt or foam, can be placed within eachof the reservoirs 125, 126, 127 to hold the ink and reduce thelikelihood of spillage and mixing.

A cover 165 extends over the top of the open reservoirs 125, 126, 127and sealably engages the perimeter 150, the first isolation space 140,and the second isolation space 145. The cover 165 inhibits spillage,mixing, drying, and contamination of the ink before and aftersterilization. In most constructions, the cover 165 is a thin plasticfilm or a thin foil that is adhesively bonded, heat sealed, or otherwiseattached to the formed portion 130. In adhesively bonded constructions,an adhesive is applied to the one or both of the cover 165 and theformed portion 130 in, or adjacent to, the perimeter 150, the firstisolation space 140, and the second isolation space 145 such that whenthe cover 165 is positioned as desired, the cover 165 adhesively bondsto the formed portion 130. Once sealed by the cover 165, the container120 and the ink can be sterilized, transported, and stored for futureuse.

It should be noted that the thin plastic cover 165 could be used withthe construction of FIG. 5 in place of, or in conjunction with, thecover 105.

To manufacture the container 120, the formed portion 130 is firststamped or injection molded from a thermoplastic material. Of courseother materials (e.g., metals, composites, and the like) and othermanufacturing processes could be used if desired. The ink holdingcomponent 160 (e.g., felt, foam, etc.) is positioned within each of thereservoirs 125, 126, 127 if employed. The different color inks are thenplaced in the individual reservoirs 125, 126, 127. Adhesive is appliedto one, or both, of the cover 165 and the formed portion 130 and thecover 165 is positioned on the formed portion 130 to complete theassembly of the container 120. The container 120 is then sterilized andpackaged for use at a future date.

FIG. 7 is a sectional view taken along the longitudinal axis of thecontainer 120 of FIG. 6. As can be seen, the perimeter 150, the firstisolation space 140 and the second isolation space 145 reside in asingle plane that allows the cover to sealably engage the container andseal each reservoir from the other reservoirs. The ridge 155 extendsdownward to increase the stiffness of the container 120 and to eliminatea thin edge that would otherwise exist and would provide a sharp surfacethat could tear a surgical glove.

In use, the constructions of FIG. 5 and FIGS. 6, 6 a, and 7 functionsimilarly. The cover 105, 165 is first opened or removed to expose theink. A first surface 50 of the tissue sample 15 is dipped into the firstreservoir 90, 125, a second surface 55 of the tissue sample 15 is dippedinto the second reservoir 95, 126, and a third surface 60 of the tissuesample 15 is dipped into the third reservoir 100, 127. In mostconstructions, quick-drying ink is used to further speed the process.Generally, quick-drying ink is ink that dries in less than about 15minutes with inks that dry in less than 5 minutes being preferred. Theink has a degree of viscosity such that it does not run or drip on thewet tissue after it is applied. Once the three surfaces 50, 55, 60 aremarked, the orientation of the tissue sample 15 is easily identified andsomeone other than the surgeon can examine the sample while accuratelyunderstanding the original orientation of the tissue within thepatient's body.

In some constructions, a label 175 is provided with the container 120 asshown in FIGS. 5 and 6. The label 175 is pre-marked with the ink colorsand a space. The nurse or surgeon can identify the surface marked witheach color ink by identifying that surface in the space adjacent thecorrect color on the preprinted label. The label 175 is then pealed offand affixed to the tissue sample 15 or the container that contains thetissue sample 15. In still other constructions, preprinted labelsinclude the colors and a preprinted surface identification, therebyeliminating the need to write the orientation on the label. In addition,some constructions include duplicate labels to allow for easyidentification on a patients chart.

It should be noted that all of the constructions illustrated anddiscussed herein could also include a stick surface 180 (shown in FIGS.6 a and 7). The stick surface reduces the likelihood of the containerslipping off of a surface when the container 80, 120 is positioned foruse. As such, the stick surface 180 is generally positioned opposite areservoir opening, as illustrated in FIGS. 6 a and 7. Many substances(e.g.; rubber, VELCRO, adhesives, and the like) can be used as a sticksurface 180.

FIG. 8 illustrates another construction of a single-use tissue markingsystem 500 that includes a container 505 preferably formed as a singleunitary piece using a thermoplastic material. The container 505 definesthree reservoirs 510 sized to contain a quantity of ink or die. Thecontainer 505 includes another compartment or space 515 sized to receivea container of fixative 520. The fixative 520 can be applied to thetissue sample before or after the ink or die is applied to improve theadhesion of the ink or die and inhibit running and drops. One fixative520 suitable for use includes vinegar or a vinegar solution, with otherfixatives 520 also being possible depending on the type of ink or dieemployed. In preferred constructions the fixative 520 is contained in abottle with a spray nozzle 525. The spray nozzle 525 assures that a finemist of fixative is sprayed onto the tissue rather than large droplets.

The container 505 defines an elongated space 530 that is sized toreceive a plurality of applicators 535. In preferred constructions, thequantity of applicators 535 equals the quantity of ink reservoirs 505.As such, the illustrated construction includes three ink reservoirs 505and three applicators 535. However, other constructions may include adifferent number of applicators 535 than reservoirs 505. For example,one construction could include six ink reservoirs 505 and threeapplicators 535. As one of ordinary skill will realize, many differentquantities of applicators 535 and reservoirs 505 can be employed. Forexample, some constructions may include six ink reservoirs 505 and sixapplicators 535.

In the illustrated construction, the elongated space 530 includes aplurality of separator elements 540 that support and separate theapplicators 535 within the space 530. The positioning within the space530 allows a surgeon or other user to easily remove the applicators 535with a gloved hand and with little risk of tearing or puncturing theglove.

Each applicator 535 includes a handle portion 545 and a sponge portion550. In preferred constructions, the handle portion 545 is formed from aplastic material. The sponge portion 550 is sized to absorb and hold adesired quantity of ink, while facilitating the accurate placement ofthe ink on the tissue sample. By depressing the sponge 550 onto thetissue sample, the surgeon is able to release a desired quantity of inkwithout causing drips or runs that can blur or confuse the marking.

A removable cover member (not shown) similar to that illustrated inFIGS. 6, 6 a, and 7 is employed to cover the container 505. The coveradhesively bonds to the container 505 and seals each ink reservoir 510from the other ink reservoirs, the fixative space 515, and the elongatedspace 530 to inhibit leakage of the inks. In preferred constructions, asingle one-piece cover is employed to expedite the opening of the inkreservoirs 510 and other spaces 515, 530.

As with the prior embodiments, the container 505 is a single-use devicethat is preferably sterilized prior to use. The user or surgeon grasps ahandle 555 and removes the cover from the container 505 to completelyexpose each of the inks for use. Each applicator 535 is used with one ofthe inks to apply the ink to the tissue sample. The fixative 520 isapplied before or after the ink is applied to assure that the inkremains fixed to the tissue sample. Once the tissue sample is properlymarked, the container 505, cover, and applicators 535 can be discarded.

As noted, other constructions of the applicator are also possible. Asillustrated in FIG. 9, one construction of an applicator 600 includes ahandle portion 605, a first sponge portion 610, and a second spongeportion 615. The first sponge portion 610 is similar to the spongeportion 550. The second sponge portion 615 includes a sponge or othermaterial that will hold a quantity of ink. However, the second spongeportion 615 includes a small edge that allows for the finer moreaccurate placement of ink should it be necessary.

As was also noted, other constructions may employ more reservoirs tohold more colors of ink and may include more applicators. For example,FIG. 10 illustrates a construction that includes a housing 900 thatdefines six reservoirs 905 that can be filled with six different colorsof ink or dye as desired. In some cases, six different color inks arepreferred to allow the surgeon to identify all six sides of the tissuesample. Alternatively, preferred colors can be used depending on thetype of tissue or tumor.

Each reservoir 905 is surrounded by a ridge 906 that engages a cover(not shown) to assure that when the cover is in place, each reservoir905 is sealed to inhibit leakage of ink from the reservoir 905.

In some constructions, each of the reservoirs 905 is labeled to aid thesurgeon in properly marking the tissue sample. For example, oneconstruction includes one of anterior, posterior, superior, inferior,medial, or lateral adjacent each of the reservoirs 905. Of course otherlabels could be employed if desired.

The construction of FIG. 10 also includes a bottle of fixative 910 andsix applicators 915 rather than the three illustrated in FIG. 8. Eachapplicator 915 would typically be used with only one color ink toinhibit mixing of colors. While the illustrated applicators 915 includea single sponge end 920, other constructions could employ the applicator600 illustrated in FIG. 9 if desired.

As with prior constructions, the housing 900 is covered with a singlecover (not shown) that seals each of the reservoirs 905 and is removableto expose each of the six reservoirs 905, applicators 915, and fixative910 for use. Once the cover is removed, the product is used for one ormore surgical procedures and then is discarded. Thus, the constructionof FIG. 10 is a single-use device.

Now that various ink marking systems in accordance with the inventionhave been described with reference to FIGS. 1-10, several exemplaryembodiments of a tissue marking clip that may be used alone or incombination with an ink-based tissue marking system will now be setforth in detail. As will be appreciated by one of ordinary skill in theart, it is not possible to identify orientation of a tissue sample in aradiographic image using different color inks. Therefore, the use of asecond marking means such as the marking clips is necessary when bothradiographic and visual examination of a tissue sample is required.

FIG. 11 illustrates an enlarged perspective view of the tissue sample 15of FIG. 4, which once again has been marked with three different colorinks 50, 55, 60 each represented by a different cross hatch pattern. Asthose of ordinary skill in the art will appreciate, any suitableink-based system may be utilized including but not limited to thosepreviously described.

FIGS. 12 and 13 illustrate one construction of a clip 230 that maydirectly engage a tissue sample 15 to identify the orientation of thetissue sample 15 in an X-ray. In preferred constructions, most or allthe clip 230 is transparent or translucent in the X-ray region of theelectromagnetic spectrum. This allows an X-ray to be taken through theclips 230 such that they do not interfere with the image. The clip 230includes a jaw portion 235, an actuator portion 240, and a tail 245. Theactuator portion 240 is substantially V-shaped and includes an apex 250and two arms 255 that connect with one another at the apex 250. In theillustrated construction, the two arms 255 cooperate to define an angle260 of about 45 degrees with other angles 260 also being possible.

In some constructions, the arms 255 include a knob 265 positioned at theend of the arm 255 opposite the apex 250. The knobs 265 make it easierto grasp and actuate the actuator portion 240 without the clip 230slipping from the user's hand or an instrument. In still otherconstructions, a texture such as ridges or other grip-enhancing surfacesmay be formed on the arms 255 to reduce the likelihood of slippageduring actuation.

The jaw portion 235 includes two teeth 270, 275 with each tooth 270, 275extending from one of the arms 255 of the actuator portion 240. Eachtooth 270, 275 is substantially curved and terminates at a point 280.The curve of each of the teeth 270, 275 is such that the two points 280are pointing substantially toward one another when the clip 230 is inthe non-actuated position.

One of the teeth 270 is slightly longer than the other tooth 275 suchthat the teeth 270, 275 cooperate to produce a slight overbite 282. Theoverbite 282 improves the grip of the teeth 270, 275 in the tissuesample 15, thereby making it less likely that the clip 230 would beaccidentally removed from the sample 15.

In some constructions, barbs or other tissue-engaging members could beformed as part of the teeth 270, 275 to further enhance their grip onthe tissue sample 15 to which they are attached. In addition, more thantwo teeth 270, 275 or teeth 270, 275 having more than one point 280could also be employed if desired.

Each tooth 270, 275 defines a tooth surface area at the tooth tip. Thesurface area is related to the biasing force produced by the clip 230.Specifically, the tooth tip surface area is sized to not puncture aglove when only the biasing force of the clip is applied. Thus, whenclips with larger biasing forces are employed, larger tooth tip surfaceareas are employed.

Each tooth 270, 275 attaches to one of the arms 255 of the actuatorportion 240 approximately one-third of the length back from the apex250. The attachment point of the teeth 270, 275 to the arms 255determines how far open, or apart the points 280 will spread when theclip 230 is in the actuated position. Thus, other constructions couldposition the teeth 270, 275 further away from the apex 250 and/or couldincrease the angle 260 defined by the arms 255 to increase the openingbetween the points 280. Likewise, the opposite arrangement could beemployed to reduce the opening if desired.

The tail 245 extends from one of the arms 255 of the actuator portion240 and includes an indicator 285 that is opaque in an X-ray region ofthe electromagnetic spectrum. In the illustrated construction, theindicator 285 includes a number of balls 290 formed as part of the tail245. The balls 290 are substantially opaque in the X-ray region of theelectromagnetic spectrum. As such, the balls 290 appear white on anX-ray. In this construction, the number of balls 290 on the tail 245indicates orientation. For example, as illustrated in FIG. 11, onesurface of the sample 15 may have a clip 230 a attached with one ball290 on the tail 245. The second surface would then include a clip 230 bwith two balls 290, and the third surface would include a clip 230 cwith three balls 290. Because the clips 230 a, 230 b, 230 c and thetails 245 travel with the sample 15, multiple X-rays at multiple anglescan be taken without losing the ability to determine the orientation ofthe tissue sample 15.

While clips 230 with tails 245 having one, two, or three balls 290 canbe provided, one construction employs tails 245 with only three balls290. The user then breaks off one ball 290 or two balls 290 to definethe different indicators 285. Furthermore, while the tail 245 is shownand described as being attached to one of the arms 255, it could beattached to nearly any portion of the actuator portion 240 or the jawportion 235 if desired.

In other constructions, other indicators 285 may be employed. Forexample, one construction uses different shaped indicators (e.g.,square, rectangular, triangular, etc.) for each clip used to identifyorientation (i.e., three clips). Still other constructions may employindicators that vary by size. For example, one construction could employa single large ball, a single medium size ball, and a single small ball(or no ball) to indicate orientation.

FIG. 15 illustrates yet another construction of a clip 330 that issuitable for use in identifying the orientation of a tissue sample. Theclip 330 is similar to the clips 230 a, 230 b, 230 c of FIGS. 11-14 withthe exception of a tail 335. The tail 335 includes an extension portion340 that connects to one of the arms 255 or some other portion of theclip 330, and an identifier portion 345 that is attached to theextension portion 340.

In the illustrated construction, the extension portion 340 is fixedlyattached to the arm 255. In preferred constructions, the extensionportion 340 is integrally-formed as part of the arm 255 or clip 330. Asillustrated in FIG. 16, the identifier portion 345 includes asubstantially plate-shaped member 350. The plate-shaped member 350defines, two relatively large planar surfaces 355 that facilitate theplacement of indicia 360 that aids in identifying the orientation of thesample 15 to which the clip 330 is attached. For example, an “L” isplaced on one of the planar surfaces 355 to indicate a lateral position.The “L” (Lateral) can be placed on the planar surface 355 using ametallic paint or other system that is visible in an X-ray image. In oneexemplary embodiment, the indicia on the planar surface 355 may beapplied with a radiographic label. As appreciated by one of ordinaryskill in the art, radiographic labels may provide a brightness that isconsistent on the X-ray image with edges that are crisp and highlylegible. Some other indicia that may be employed includes A forAnterior/Superficial, P for Posterior/Deep, S for Superior/Cephalad, Ifor Inferior/Caudal, and/or M for Medial. Of course other indicia couldbe employed so long as the surgeon and the radiologist or pathologistunderstand their meaning.

As illustrated in FIGS. 16 and 17, the identifier portion 345 attachesto the extension portion 340 using a ball-and-socket joint 365. In theillustrated construction, a socket 370 is formed in the identifierportion 345 and a ball 375 is formed at the end of the extension portion340. The ball 375 fits within the socket 370 and allows movement of theidentifier portion 345 with respect to the extension portion 340 and theremainder of the clip 330.

Thus, the clip 330 of FIGS. 15-17 includes an identifier portion 345that is articulatable with respect to the remainder of the clip 330 towhich it is attached. In one construction, the identifier portion 345 isarticulatable with respect to the extension portion 340. In anotherconstruction, the extension portion 340 is articulatable with respect tothe remainder of the clip 330 and the identifier portion 345 is fixedwith respect to the extension portion 340. In this construction, theball-and-socket joint 365, or other joint is formed between the arm 255and the extension portion 340 similar to the one illustrated in FIG. 12.In still other constructions, both the extension portion 340 and theidentifier portion 345 are articulatable with respect to the remainderof the clip 330. These constructions would employ two joints. As one ofordinary skill in the art will recognize, each of these examplesdescribe an arrangement in which the identifier portion 345 isarticulatable with respect to the remainder of the clip 330 to allow anX-ray technician to position the identifier portion 345 for optimumviewing in an X-ray image.

One of ordinary skill in the art will realize that many differentindicators 285 can be employed so long as they are easily identifiablefrom any angle on an X-ray image. In addition, while only three clips230, 330 are required to define an orientation, any number of clips 230,330 can be employed (e.g., six clips). In addition, a single clip can beemployed if desired to identify an area of interest rather than a tissueorientation.

As illustrated in FIG. 13, a width 295 of the clip 230 is small enoughto allow the tissue sample 15 and the clip 230 to be compressed duringthe X-ray process without affecting the connection of the clip 230 andwithout the clips 230 interfering with the process.

In preferred constructions, the actuator portion 240 and the jaw portion235 are integrally-formed as a single component. For example, in oneconstruction, the actuator portion 240 and the jaw portion 235 areinjection molded as a single part in one manufacturing step. Byintegrally-molding the actuator portion 240 and the jaw portion 235, theoverall cost of the clip 230 is reduced.

In more preferred constructions, the actuator portion 240, the jawportion 235, and the tail 245 or a portion of the tail 245 areintegrally-formed as a single component. In these constructions theactuator portion 240, the jaw portion 235, and the tail 245 can be madefrom one material in a single injection molding step. Alternatively, twodifferent materials could be used with the actuator portion 240 and thejaw portion 235 being made from a material that is translucent in theX-ray region of the electromagnetic spectrum, and the tail 245 beingmade from a more opaque material. In these constructions, a co-moldingor two step injection molding process may be employed.

With reference again to FIGS. 11, 14, and 15, the use of the clip 230will be described. Once the tissue sample 15 is removed from thepatient, one or more of the surfaces is marked using an ink-based markeras previously described. The actuator portion 240 of the first clip 230a is grasped and compressed to move the clip 230 a into the actuatedposition as shown in FIG. 14. It should be noted that FIG. 14illustrates an Alice Clamp 300 holding the clip 230 a in the actuatedposition. However, the clip 230 a can also be actuated using othersurgical instruments (e.g., clamps, forceps, etc.) or a user's fingers.Once in the actuated position, the points 280 of the teeth 270, 275 arepositioned adjacent the surface of the tissue sample 15 to be marked andthe actuator portion 240 is released. Once released, the teeth 270, 275move to their non-actuated positions and the points 280 engage thetissue sample 15. These steps are repeated for each additional clip 230b, 230 c that is attached to the tissue sample 15. Generally, threeclips 230 a, 230 b, 230 c are required to identify the orientation ofthe sample 15. However more or fewer clips 230 can be employed ifdesired. Furthermore, the three clips 230 a, 230 b, 230 c may beattached to the same surfaces that were marked with ink, or differentsurfaces if desired.

When using the clips 330 of FIGS. 15-17, once the clips 330 areattached, an X-ray technician or other user is able to articulate theidentifier portions 345 of the various clips 330 to provide optimumviewing in any X-ray images. Thus, the X-ray technician is able toreorient the tissue sample 15 as desired without worrying about losingthe orientation and with the knowledge that the identifier portions 345can be reoriented as required to provide the optimum view of the indicia360 in any X-ray images.

In one construction, the clips 230 a, 230 b, 230 c are provided with theink system and are color coded to match the ink colors 50, 55, 60. Thus,the tissue sample 15 is marked with ink 50, 55, 60 and the clips 230 a,230 b, 230 c are then attached to the surface of the tissue sample 15corresponding to their particular color.

Once the tissue sample 15 is marked with both ink and the clips 230,both X-ray and visual inspection can be performed without confusing theorientation of the tissue sample 15.

Thus, the invention provides, among other things, a new and usefulmarking system for use in marking the orientation of a tissue sample 15.The constructions of the clip 230 and the methods of using the clip 230described above and illustrated in the figures are presented by way ofexample only and are not intended as a limitation upon the concepts andprinciples of the invention.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A tissue marking system for use in marking atissue sample, the system comprising: an ink-based applicator deviceincluding: a container; a plurality of ink reservoirs at least partiallydefined by the container, each of said plurality of ink reservoirscontaining an ink of a different color; and a cover coupled to andcooperating with the container, said cover configured to fully enclosesaid plurality of ink reservoirs; and a plurality of tissue markingclips wherein said plurality of tissue marking clips is equal in numberto the plurality of ink reservoirs, said plurality of tissue markingclips each including: an actuator portion, said actuator portion movablebetween an actuated position and a non-actuated position; a jaw portioncoupled to the actuator portion and movable between an open position anda closed position in response to movement of the actuator portion fromthe non-actuated position to the actuated position, the jaw portionincluding a first tooth and a second tooth configured to engage thetissue sample when the jaw portion moves from the open position to theclosed position; a coupling mechanism on one of said actuator portionand said jaw portion; and a radiographic indicator configured to bereceived by said coupling mechanism, and further configured to rotatewithin said coupling mechanism relative to said one of said actuatorportion and said jaw portion during an imaging procedure, wherein saidink-based applicator device and said plurality of tissue marking clipsare configured to be used in combination on a tissue sample therebyproviding both visual and radiographic identification of an orientationof the tissue sample to a radiologist, surgeon or pathologist.
 2. Thetissue marking system of claim 1, wherein the plurality of inkreservoirs equals three.
 3. The tissue marking system of claim 1,further comprising a fixative disposed within the container.
 4. Thetissue marking system of claim 1, wherein the container defines anelongated space housing a plurality of applicators equal to theplurality of ink reservoirs, the cover and the container configured tofully enclose the plurality of applicators.
 5. The tissue marking systemof claim 4, wherein the cover comprises a single, removable cover thatforms an adhesive bond with the container, said cover thereby sealingeach ink reservoir from the other ink reservoirs and from the elongatedspace.
 6. A tissue marking system for use in marking a tissue sample,the system comprising: an ink-based applicator including a containerdefining a space; a plurality of ink reservoirs at least partiallydefined by the container, each of said plurality of ink reservoirscontaining an ink of a different color; a plurality of applicatorsdisposed within the space, each applicator configured to absorb aquantity of ink for application to the tissue sample; a fixativedisposed within the space; a single cover coupled to the container, saidsingle cover fully enclosing said plurality of ink reservoirs and thespace; and a plurality of tissue marking clips whose number equals thenumber of said plurality of ink reservoirs, each of the tissue markingclips including a first jaw portion movable between a closed positionand an open position, the first jaw portion configured to engage thetissue sample when moved from the open position to the closed position,said first clip including first receiving means thereon; a firstradiographic indicator configured to be received by said first receivingmeans and including first indicia that is opaque to radiographicexamination, and further configured to rotate within said firstreceiving means during an imaging procedure; wherein at least one ofsaid plurality of tissue marking clips is transparent to radiographicexamination, and further wherein said ink-based applicator and saidplurality of clips are configured to be used in combination to mark atissue sample thereby providing both visual and radiographicidentification of an orientation of the tissue sample to a radiologist,surgeon or pathologist.
 7. The tissue marking system of claim 1, whereinthe first tooth includes a first tip and the second tooth includes asecond tip, and wherein the first tip is offset a non-zero distance fromthe second tip defining an overbite when the jaw portion is in theclosed position.
 8. The tissue marking system of claim 1, wherein theactuator portion includes a first arm and a second arm connected to thefirst arm to define an apex.
 9. The tissue marking system of claim 8,wherein the first tooth attaches to the first arm and the second toothattaches to the second arm.
 10. The tissue marking system of claim 1,wherein the radiographic indicator is configured to be identifiable in aradiographic examination.
 11. The tissue marking system of claim 10,wherein the radiographic indicator includes an identifier portioncoupled to the tail portion wherein the tail portion is configured to berotatably coupled to said coupling mechanism.
 12. The tissue markingsystem of claim 10, wherein the jaw portion and the actuator portion aretransparent to radiographic examination, and wherein the indicatorportion includes indicia that is opaque to radiographic examination. 13.A tissue marking system for use in marking a tissue sample, the systemcomprising: an ink-based applicator device including: a container; aplurality of ink reservoirs at least partially defined by the container,each of said plurality of ink reservoirs containing an ink of adifferent color; and a cover coupled to and cooperating with thecontainer, said cover fully enclosing said plurality of ink reservoirs;and a plurality of tissue marking clips, wherein said plurality oftissue marking clips is equal in number to said plurality of inkreservoirs, each of said plurality of tissue marking clips including: anactuator portion including two arms at least one of said two armsincluding a coupling mechanism thereon, said actuator portion movablebetween an actuated position and a non-actuated position; an indicatorhaving a tail portion including a ball formed on an end thereof, saidball configured to engage and rotate within with said couplingmechanism; a jaw portion coupled to the actuator portion and movablebetween an open position and a closed position in response to movementof the actuator portion from the actuated position to the non-actuatedposition, the jaw portion including a first tooth and a second toothconfigured to engage the tissue sample when the jaw portion moves fromthe open position to the closed position, wherein said jaw portion andsaid actuator portion are transparent to radiographic examination,wherein said ink-based applicator device and said plurality of tissuemarking clips are configured to be used in combination with each otheron a tissue sample thereby providing both visual and radiographicidentification of an orientation of the tissue sample to a radiologist,surgeon or pathologist.
 14. The tissue marking system of claim 13wherein said tail portion further includes an indicator.
 15. The tissuemarking system of claim 13 wherein said jaw portion and said actuatorportion are transparent in an X-ray region of an electromagneticspectrum.
 16. The tissue marking system of claim 14 wherein saidindicator is radio opaque.
 17. The tissue marking system of claim 1, 6or 13 wherein each of said plurality of tissue marking clips is colorcoded to match an inks of different color.